Quality Control Technician

The Quality Control Associate is responsible for the efficient coordination of QC sample shipment and testing activities, ensuring accurate tracking, documentation, and compliance with GxP standards. This role provides critical QC support to Quality Operations, Validation, Analytical Services, Manufacturing, and Clinical Supplies functions.

The position plays a key role in maintaining quality documentation, supporting lot disposition activities, and ensuring timely communication across internal teams and external testing organizations (CTOs).

• Coordinate shipment of QC samples, log and track testing submissions at Contract Testing Organizations (CTOs), and collate assay results.
• Review QC data for accuracy, completeness, and compliance.
• Maintain and update quality databases.
• Review shipment receipt documentation and release records for quality assessment.
• Prepare and manage quality documentation including SOPs, deviations, and change controls related to QC activities.

• Prepare quality documentation in a timely manner to support QA review and lot disposition decisions.
• Monitor and manage QC testing turnaround time metrics.
• Support cross-functional collaboration with Quality Operations, Validation, Analytical Services, Manufacturing, and Clinical teams.

• Track and reconcile invoices related to external testing at CTOs.
• Proactively communicate project status, risks, and critical issues to management and relevant project team members.

• Bachelor’s degree (or higher) in Life Sciences or a related discipline.
• Experience working in a regulated GxP-compliant environment.
• Experience with quality systems and regulatory compliance within pharmaceutical or biotechnology environments.
• Ability to manage multiple activities simultaneously and coordinate across departments and organizational levels.
• Comfortable working in a fast-paced, results-driven environment.
• Highly organized with strong attention to detail.
• Sound judgment and decision-making capability.
• Proactive and self-motivated with demonstrated initiative.
• Strong written and verbal communication skills.

Salary Range: 70,000 – 80,000 base + 10% bonus